BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCULIGHT

    MDR report key: 829842 · Received March 9, 2007

    Report

    Report Number
    2914019-2006-00101
    Event Type
    Other
    Date Received
    March 9, 2007
    Report Date
    March 9, 2007
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DETAILS REGARDING THE ALLEGED INJURY WERE AVAILABLE AT THE TIME OF THE INITIAL INVESTIGATION BY LUMENIS, AND NO FURTHER INVESTIGATION WAS POSSIBLE. THE COMPLAINT WAS CLOSED UNTIL SUCH TIME AS DISCOVERY MAY YIELD ADD'L DETAILS FOR INVESTIGATION. OTHER CUSTOMER DID NOT MAKE THE DEVICE AVAILABLE FOR EVALUATION BY LUMENIS. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO BE MDR REPORTABLE. THIS INCIDENT WAS LATER RECLASSIFIED BY LUMENIS AS MDR REPORTABLE AS A RESULT OF AN INTERNAL AUDIT AND THE FDA LETTER DATED JULY 25, 2006.

    Description of Event or Problem · 1

    THIS IS A LEGAL MATTER BETWEEN THE PHYSICIAN AND HIS PT. THE PT'S ATTORNEY REPORTED THE ALLEGED SAFETY INCIDENT TO LUMENIS ON OR ABOUT 04/26/2006, ALLEGING THAT THE PT HAD BEEN INJURED IN CONNECTION WITH A VASCULIGHT TREATMENT. NO OTHER DETAILS, INCLUDING THE DATE OF THE ALLEGED INCIDENT, WERE PROVIDED TO LUMENIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULIGHT COMBINATION INTENSE PULSE LIGHT DEVICE AND SOLID STATE LASER GEX LUMENIS LTD VASCULIGHTSB *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other NONE REPORTED.